The Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation, established by the European Union in 2007, aims to protect human health and the environment from the risks posed by chemicals. A critical component of REACH is the identification and regulation of Substances of Very High Concern (SVHC). These substances, due to their hazardous properties, require stringent control and monitoring by industrial manufacturers to ensure compliance and safety. Read more about what these substances are here.
Understanding SVHC Categories
SVHCs are identified based on their hazardous properties. There are several categories that these fall into.
- Carcinogenic, Mutagenic, or Toxic to Reproduction (CMR): These chemicals can cause cancer, genetic mutations, or reproductive harm.
- Persistent, Bioaccumulative, and Toxic (PBT): These substances persist in the environment, accumulate in living organisms, and exhibit toxicity.
- Very Persistent and Very Bioaccumulative (vPvB): These chemicals are similar to PBTs but with greater persistence and bioaccumulation potential.
- Equivalent Level of Concern (ELoC): This category includes those substances that pose serious health or environmental risks, such as endocrine disruptors.
The SVHC Candidate List and Authorisation List
The list of SVHC candidates maintained by the European Chemicals Agency (ECHA) is dynamic and updated biannually. As of January 2024, this list includes 240 chemicals.
Substances on this list are candidates for the Authorisation List (Annex XIV of REACH). Once a substance is added to the Authorisation List, it is assigned a “sunset date,” beyond which its use is prohibited unless explicitly authorized. I.e it can only be used in very specific circumstances, with prior authorization.
Compliance Requirements for Industrial Manufacturers
There are a number of compliance requirements that industrial manufacturers must adhere to in order to manage SVHCs effectively:
- Notification: Manufacturers must notify the ECHA if an SVHC is present in their products above a concentration of 0.1% or in quantities exceeding one metric ton annually. This notification must be completed within six months of the substance being added to the SVHC list.
- Communication: Safety information regarding SVHCs must be communicated to professional users and distributors.
- Consumer Response: Upon request, manufacturers must provide consumers with safe use information for products containing SVHCs within 45 days.
- Safety Data Sheets: Detailed safety data sheets must accompany products to inform users about hazards and safe handling practices.
Implications for Industrial Manufacturers
Compliance with REACH SVHC regulations is not optional for industrial manufacturers. They must comply with the regulations to avoid severe consequences. Non-compliance can result in hefty fines, market disruptions, and damage to a company’s reputation.
Therefore, understanding and implementing the following steps are crucial:
- Identify SVHCs in Your Supply Chain: Regularly review the ECHA’s Candidate List and assess whether any SVHCs are present in your products or supply chain.
- Implement a Robust Compliance Strategy: Develop a comprehensive strategy that includes regular audits, employee training, and supplier assessments to ensure ongoing compliance.
- Engage in Substitution Planning: If your products contain SVHCs, explore alternatives or substitutes that are less hazardous. This proactive approach not only aids in compliance but also demonstrates a commitment to sustainability.
- Maintain Detailed Documentation: Keep meticulous records of your compliance efforts, including notifications, communications, and safety data sheets. This documentation is essential in the event of regulatory audits or inquiries.
Stay Informed about Additions to the SVHC List
Staying informed about the latest additions to the SVHC list is vital for industrial manufacturers. Substances are added to this list often and the list should be perused by industrial manufacturers on a regular basis.
For detailed information on the latest SVHC updates and compliance guidelines, you can look at the European Chemicals Agency website where they have a tab that allows you to search for chemicals and filter through the list.
The website page gives you the substance name, date of inclusion, reason for inclusion, a link to the decision to include, and the EC and CAS numbers which is helpful for industrial manufacturers to aid them in ensuring compliance. Read more about magazinehub.
REACH SVHC regulations are an important part of the EU’s efforts to control hazardous chemicals and to protect both public health and the environment. For industrial manufacturers, compliance with these regulations is not just a legal obligation but rather a vital component of corporate responsibility and sustainability. By understanding what the different SVHC categories are, adhering to notification and communication requirements, and staying informed about updates to the SVHC list, manufacturers can ensure they meet regulatory standards while contributing to a safer, healthier environment.
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